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Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

ConditionFamilial Hypercholesterolemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

Familial hypercholesterolemia is the most common inherited disease of the lipid metabolism, however it remains underdiagnosed. Only 15 % of 30.000 possible patients have been found in Denmark. This quality assessing project will through a step wedge cluster randomized controlled trial evaluate establishment of a biochemistry interpretive comment on elevated LDL-C levels. The study will test if the comment results in an increase in referred patients to the lipid clinics of Southern Denmark as the primary endpoint, and as the secondary endpoint in more patients diagnosed with familial hypercholesterolemia. The project will run in totally 52 weeks and will in steps initiate the comment from the different laboratories in the Region of Southern Denmark.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All referred patients to the lipid clinics of Southern Denmark

LDL-C ≥ 4 mmol/L in persons under the age of 40.

LDL-C ≥ 5 mmol/L in persons ≥ 40 years.

Disqualifiers

Dysregulated diabetes. Hba1C < 48

Dysregulated hypothyreosis. Elevated TSH.

Kombined hyperlipidiemia TG > 4 mmol/L

Nefrotic syndrome: proteinuria > 3 g/L and s-albumin < 30 g/l

Trial design

Design model

Sequential

Treatments tested in this trial

  • Biochemistry interpretive comment on elevated LDL-C levels

    Other intervention

    The interpretive comment on LDL-C will encourage for excluding secondary dyslipidemia (measuring Hba1C, TSH and checking current drugs and talk about diet). If secondary dyslipidemia ca be excluded we encourage to referral to lipid clinic. Familial hypercholesterolemia should be suspected if LDL-C ≥ 4 mmol/L in persons under the age of 40, or LDL-C ≥ 5 mmol/L in persons ≥ 40. The biochemistry interpretive comment will thus be released to the referring physician if the blood sample meet the criteria above. We advice that in pregnant women to control elevated LDL-C after childbirth.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Biochemistry interpretive comment on LDL-C levelsExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of patients reffered to lipid clinic

Proportion of referred patients to lipid clinics in the region of Southern Denmark after establishment of interpretive comment on LDL-C, compared to proportion before the comment.

Time frame
12-18 months
2

Diagnosed patients with Familial Hyperchoelsterolemia

Proportion of patients diagnosed with familial hypercholesterolemia (Dutch clinical lipid score ≥ 6) in the Region of Southern Denmark after establishment of interpretive comment on LDL-C, compared to proportion before the comment.

Time frame
During 9-12 months due to waiting time for genetic test

Secondary outcomes

1

Change in LDL-C

Change in LDL-C levels from referral to first contact in lipid clinic

Time frame
3-6 months
2

Familial hypercholesterolemia mutations

Number of genetic test with mutations related to familial hypercholesterolemia

Time frame
9-12 months due to waiting time for genetic test
3

Hba1C

Mean Hba1C at referral as baseline value

Time frame
3 months
4

TSH

Mean TSH at referral as baseline value

Time frame
3 months

Other outcomes

Sponsors and contacts

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Odense University Hospital

Lead sponsor

Source ClinicalTrials.gov
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